Preventing Severe Hypoglycemia in Type 2 Diabetes: Randomized Controlled Trial of Proactive Care With Versus Without...

Severe hypoglycemia is a feared complication of diabetes treatment. While psychoeducational programs reduce severe hypoglycemia in type 1 diabetes, their effectiveness is unclear in type 2 diabetes (T2D).

The Preventing Severe Hypoglycemia in Adults with Type 2 Diabetes (PHT2) randomized trial compared (a) proactive nurse care management (PC) and (b) PC augmented with my hypo compass for adults with T2D, a psychoeducational intervention (PC+).

Adults with T2D on insulin or sulfonylurea and with a severe event in the prior 12 months or impaired awareness of hypoglycemia.

Primary outcome was self-reported severe hypoglycemia over 12 months, assessed at 14 months.

Ninety-two percent (n = 230) of 259 participants (67.2 ± 10.6 years; 61% women) completed the trial. The proportion reporting ≥ 1 severe hypoglycemia event in the 12 months before baseline was 34.1% in the PC arm and 24.8% in the PC + arm. At 14 months, severe hypoglycemia did not differ significantly between arms (16.1% PC vs 11.6% PC + ; adjusted relative risk [aRR] 0.72 [95% confidence interval, 0.39 to 1.30]; adjusted absolute risk difference [aARD] -4.6 [95% confidence interval, -13.0 to 3.7]). Level 2 hypoglycemic events (glucose < 54 mg/dL for ≥ 15 min) were less frequent in the PC+ arm on the absolute risk scale but not on the relative risk scale (aRR 0.46 [95% confidence interval, 0.20 to 1.03]; aARD, -11.3% [95% confidence interval, -21.7 to -0.8]). No other secondary measures differed significantly between arms.

Adding psychoeducational training to proactive care did not significantly reduce self-reported severe hypoglycemia compared to proactive care alone, with both groups experiencing a 50% reduction in severe hypoglycemia. Results should be interpreted with caution due to limited power.

ClinicalTrials.gov Identifier: NCT04863872.